Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction

Postpartum Depression Clinical Trial

Official title:

Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057627
• Other study ID #: 1R21HD065156-01
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: April 19, 2016
• Start date: June 2010
• Est. completion date: July 2012

Study information

• Verified date: April 2016
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. The purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of PDP. Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the PDP intervention or a control condition. The PDP intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. Control mothers will receive usual care plus depression monitoring by phone. Data will be collected at baseline, post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First-time, English-speaking mothers of healthy singleton newborns

• Positive screen (> 10) on Edinburgh Postnatal Depression Scale

Exclusion Criteria:

• Suicidal ideation

• Currently receiving depression treatment

• Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• Perinatal Dyadic Psychotherapy
8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months
• Placebo Comparator
Standard care plus depression monitoring by phone

Locations

Country	Name	City	State
United States	MGH Insiitute of Health Professions	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Goodman JH, Guarino AJ, Prager JE. Perinatal dyadic psychotherapy: design, implementation, and acceptability. J Fam Nurs. 2013 Aug;19(3):295-323. doi: 10.1177/1074840713484822. Epub 2013 Apr 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)		baseline, 3 months (post-intervention) and 6 months (follow-up)	No
Primary	Change from baseline in maternal depressive symptom scores immediately following the 3 month intervention and at 3 months post-intervention as measured by the Edinburgh Postnatal Depression Scale		baseline, 3 months (post-intervention) and 6 months (follow-up)	No
Primary	Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention		3 months (post-intervention) and 6 months (follow-up)	No
Secondary	Change from baseline in maternal anxiety diagnosis immediately following the 3 month intervention and at 3 months post-intervention per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)		baseline, 3 months (post-intervention) and 6 months (follow-up)	No
Secondary	Maternal parenting stress immediately following the 3 month intervention and at 3 months post-intervention as measured by the Parenting Stress Index - Short Form (PSI-SF)		3 months (post-intervention) and 6 months (follow-up)	No
Secondary	Change from baseline in maternal anxiety symptom level immediately following the 3 month intervention and at 3 months post-intervention as measured by the State-Trait Anxiety Inventory - State (STAI-State)		baseline, 3 months (post-intervention), 6 months (follow-up)	No